US2025049937A1PendingUtilityA1

Novel auristatin analogs and immunoconjugates thereof

Assignee: ADCENTRX THERAPEUTICS INCPriority: Dec 23, 2021Filed: Dec 21, 2022Published: Feb 13, 2025
Est. expiryDec 23, 2041(~15.4 yrs left)· nominal 20-yr term from priority
C07K 5/101A61P 35/00A61K 47/68031A61K 47/6855C07K 5/06052
54
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Claims

Abstract

The invention provides novel auristatin analogs and immunoconjugates thereof, as well as pharmaceutical compositions and methods of preparation and use for treating various diseases and disorders (e.g., cancer).

Claims

exact text as granted — not AI-modified
1 . A compound having the structural formula (I): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, 
         wherein 
         R 1  is 
       
       
         
           
           
               
               
           
         
       
       wherein R 2  is a unsubstituted or substituted C 1 -C 6  alkyl, heteroalkyl, cycloalkyl or cycloheteroalkyl;
 each of R a , R b  and R c  is selected from H and NR x R y , provided that only one of R a , R b  and R c  is NR x R y  and each of the others is H; 
 each of R x  and R y  is independently selected from R, R r  and L-R z , provided that when one of R x  and R y  is L-R z  or R r , the other is R; 
 R 5  is H or CR′ 3 , wherein each R′ is independently H or F; 
 L is a linker; 
 R r  is (C═O)—O—(CH 2 ) p —R v  or (C═O)—(CH 2 ) q —R v ; 
 R v  is R, OR, NHR, NR 2 , an aryl group or an amino acid; 
 p is 0, 1, 2, 3, 4, 5 or 6; 
 q is 0, 1, 2, 3, 4, 5 or 6; 
 R z  comprises a functional or reactive group; and 
 R is H or a C 1 -C 3  alkyl. 
 
     
     
         2 . The compound of  claim 1 , wherein 
       
         
           
           
               
               
           
         
       
       has the following chirality: 
       
         
           
           
               
               
           
         
       
     
     
         3 . The compound of  claim 1 , wherein 
       
         
           
           
               
               
           
         
       
       has the following chirality: 
       
         
           
           
               
               
           
         
       
     
     
         4 . The compound of  claim 1 , wherein R 5  is CH 3 . 
     
     
         5 . (canceled) 
     
     
         6 . The compound of  claim 1 , wherein R 5  is H. 
     
     
         7 - 11 . (canceled) 
     
     
         12 . The compound of  claim 1 , having the structural formula (III a ): 
       
         
           
           
               
               
           
         
       
     
     
         13 . The compound of  claim 1 , having the structural formula (III b ): 
       
         
           
           
               
               
           
         
       
     
     
         14 . The compound of  claim 12 , wherein R x  is H and R y  is H, having the structural formula (III 1   a ): 
       
         
           
           
               
               
           
         
       
     
     
         15 . The compound of  claim 13 , wherein R x  is H and R y  is H, having the structural formula (III 1   a ) and (III 1   b ): 
       
         
           
           
               
               
           
         
       
     
     
         16 . The compound of  claim 13 , wherein R x  is H or CH 3  and R y  is (C═O)—O—(CH 2 ) p —R v , wherein R′ is R, OR, NHR, NR 2 , an aryl group or an amino acid, and p is 0, 1, 2 or 3. 
     
     
         17 . The compound of  claim 13 , wherein R x  is H or CH 3  and R y  is (C═O)—(CH 2 ) q —R v , wherein R v  is R, OR, NHR, NR 2 , an aryl group or an amino acid and q is 0, 1, 2 or 3. 
     
     
         18 . The compound of  claim 12 , wherein R y  is L-R z , having the structural formula (III 2   a ): 
       
         
           
           
               
               
           
         
       
     
     
         19 . The compound of  claim 13 , wherein R y  is L-R z , having the structural formula (III 2   b ): 
       
         
           
           
               
               
           
         
       
     
     
         20 . The compound of  claim 18 , wherein R x  is H, having the structural formula (III 3   a ): 
       
         
           
           
               
               
           
         
       
     
     
         21 . The compound of  claim 19 , wherein R x  is H, having the structural formula (III 3   b ): 
       
         
           
           
               
               
           
         
       
     
     
         22 - 41 . (canceled) 
     
     
         42 . The compound of  claim 1 , wherein R 1  is 
       
         
           
           
               
               
           
         
       
       wherein each of R 3  and R 4  is independently H or an unsubstituted or substituted C 1 -C 5  alkyl, or together with the N and C atoms they are boned to form a 5- to 7-membered heterocycloalkyl comprising one or more of O, N and S, optionally substituted with one or more of halogen atoms or C 1 -C 3  alkyl. 
     
     
         43 . The compound of  claim 1 , wherein R 1  is 
       
         
           
           
               
               
           
         
         wherein each of R 3  and R 4  is independently H or an unsubstituted or substituted C 1 -C 5  alkyl, or together with the N and C atoms they are boned to form a 5- to 7-membered heterocycloalkyl comprising one or more of O, N and S, optionally substituted with one or more of halogen atoms or C 1 -C 3  alkyl. 
       
     
     
         44 - 47 . (canceled) 
     
     
         48 . The compound of  claim 1 , wherein R 1  is selected from: 
       
         
           
           
               
               
           
         
       
     
     
         49 . The compound of  claim 1 , wherein L is a noncleavable linker. 
     
     
         50 . The compound of  claim 1 , wherein L is a cleavable linker. 
     
     
         51 - 56 . (canceled) 
     
     
         57 . A compound selected from the table below: 
       
         
           
                 
               
                     
                 
                                     
 1 
                 
                     
                 
                                     
 2 
                 
                     
                 
                                     
 3 
                 
                     
                 
                                     
 4 
                 
                     
                 
                                     
 5 
                 
                     
                 
                                     
 6 
                 
                     
                 
                                     
 7 
                 
                     
                 
                                     
 8 
                 
                     
                 
                                     
 9 
                 
                     
                 
                                     
 10 
                 
                     
                 
                                     
 11 
                 
                     
                 
                                     
 12, 13 
                 
                     
                 
                                     
 14, 15 
                 
                     
                 
                                     
 16, 17 
                 
                     
                 
                                     
 18, 19 
                 
                     
                 
                                     
 20 
                 
                     
                 
                                     
 21 
                 
                     
                 
                                     
 22 
                 
                     
                 
                                     
 23 
                 
                     
                 
                                     
 24 
                 
                     
                 
                                     
 25 
                 
                     
                 
                                     
 26 
                 
                     
                 
                                     
 27 
                 
                     
                 
                                     
 28 
                 
                     
                 
                                     
 29 
                 
                     
                 
                                     
 30 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         58 . A drug-linker conjugate formed by conjugation of a compound of  claim 1  with a linker. 
     
     
         59 . An immunoconjugate formed by conjugation of a compound of  claim 1 , via a linker, with an antigen binding moiety. 
     
     
         60 . An immunoconjugate having the structural formula (VI): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, 
         wherein 
         Ab represents an antigen binding moiety; 
         R 1  is 
       
       
         
           
           
               
               
           
         
       
       wherein R 2  is a unsubstituted or substituted C 1 -C 6  alkyl, heteroalkyl, cycloalkyl or cycloheteroalkyl;
 each of R x  and R y  is independently selected from R and L-R z , provided that when one of R x  and R y  is NR z , the other is R; 
 R 5  is H or CR′ 3 , wherein each R′ is independently H or F; 
 L is a linker; and 
 R is H or a C 1 -C 3  alkyl; 
 i is an integer in the range of 1 to about 20. 
 
     
     
         61 - 82 . (canceled) 
     
     
         83 . A method for treating or reducing a disease or condition, comprising administering to a subject in need thereof a therapeutically effective amount of an immunoconjugate of  claim 60 . 
     
     
         84 - 89 . (canceled)

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